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Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes (HIT)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
High intensity interval training
Sponsored by
German Diabetes Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes focused on measuring type 2 diabetes, exercise intervention, high intensity interval training

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Men and women
  • Age: 30 - 65 years
  • Typ-2-Diabetes (BMI > 25 kg/m²)
  • Increased risk for diabetes (BMI >25 kg/m²)

Exclusion criteria:

  • Acute Infection within the last 2 weeks prior to the intervention
  • Autoimmune diseases and immune suppressive diseases (Leukocytes < 5000/μl)
  • Intake of immunomodulating drugs (Glucocorticoids, Antihistamine, ASS)
  • Pregnancy, Breastfeeding, Menstruation
  • Kidney insufficiency (Creatinine > 1,5 mg/dl)
  • Cardiovascular diseases
  • Anemia (Hb < 12g/l), disorders of wound healing or blood clotting
  • Participation in another study within the last 2 months before the investigation
  • Metallic or magnetic items on or in the body
  • Claustrophobia
  • Thyroid dysfunction
  • Intake of glitazones or insulin therapy
  • Smoking (Non-smoking since > 1 year), alcohol consumption (Men > 30 g/d, Women > 20g/d) or illegal drugs
  • Psychiatric disorders
  • Risk for/or manifest AIDS (HIV) or Hepatitis B or C
  • Night shift working
  • Hypersensitivity to local anesthetics
  • Cancer disease
  • Lung diseases
  • Systematic endurance training (>1x per week > 60min.)
  • Maximal oxygen consumption (VO2 max) <20ml/min/kg
  • Orthopedic disorders
  • Musculoskeletal diseases

Sites / Locations

  • German Diabetes Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

high intensity interval training

Arm Description

30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week

Outcomes

Primary Outcome Measures

Improvement of Insulin sensitivity by high intensity interval training
High intensity interval training leads to significant improvements in insulin action and oxidative phosphorylation in skeletal muscle.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2012
Last Updated
August 7, 2023
Sponsor
German Diabetes Center
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1. Study Identification

Unique Protocol Identification Number
NCT02039934
Brief Title
Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes
Acronym
HIT
Official Title
Effect of High-intensity Low-volume Training on Insulin Sensitivity in Patients With Type 2 Diabetes and Healthy Lean Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Diabetes Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
High intensity interval training is applied for several diseases. Hypothesis: High intensity interval training improves insulin sensitivity in patients with type 2 diabetes.
Detailed Description
Type 2 diabetes mellitus is a multifactorial metabolic disease that is characterized by reduced insulin sensitivity and insulin production leading to impaired glucose tolerance. Overweight and low physical activity are the main risk factors for the development of type 2 diabetes. Increased physical activity has shown to improve insulin sensitivity, hence, exercise plays a significant role in the prevention and therapy of type 2 diabetes. This study aims at investigating the acute and chronic effects of high-intensity low-volume training, that consists of brief bursts of very vigorous exercise separated by recovery periods, on metabolic function in patients with type 2 diabetes, people at high risk for the disease and healthy, lean individuals. Study participants take part in 30 min training session three times a week for a period of 12 weeks. Participants are studied on four occasions, prior to the intervention, after an acute bout of exercise as well as after 6 and 12 weeks of training in order to assess physical fitness, body composition, insulin sensitivity, energy metabolism in muscle, adipose tissue inflammation and neurological function. It is hypothesized that this type of exercise leads to significant improvements in insulin action and oxidative phosphorylation in muscle

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
type 2 diabetes, exercise intervention, high intensity interval training

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high intensity interval training
Arm Type
Experimental
Arm Description
30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week
Intervention Type
Other
Intervention Name(s)
High intensity interval training
Intervention Description
The intervention consists of 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week. Training program: After 5 minutes of warm-up the subject cycles for 10 intervals of 60 s. at 90 % maximum effort separated 60 s at 20% maximum effort, based on a previously performed spiroergometry, followed by 5 minutes of cool-down.
Primary Outcome Measure Information:
Title
Improvement of Insulin sensitivity by high intensity interval training
Description
High intensity interval training leads to significant improvements in insulin action and oxidative phosphorylation in skeletal muscle.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Men and women Age: 30 - 65 years Typ-2-Diabetes (BMI > 25 kg/m²) Increased risk for diabetes (BMI >25 kg/m²) Exclusion criteria: Acute Infection within the last 2 weeks prior to the intervention Autoimmune diseases and immune suppressive diseases (Leukocytes < 5000/μl) Intake of immunomodulating drugs (Glucocorticoids, Antihistamine, ASS) Pregnancy, Breastfeeding, Menstruation Kidney insufficiency (Creatinine > 1,5 mg/dl) Cardiovascular diseases Anemia (Hb < 12g/l), disorders of wound healing or blood clotting Participation in another study within the last 2 months before the investigation Metallic or magnetic items on or in the body Claustrophobia Thyroid dysfunction Intake of glitazones or insulin therapy Smoking (Non-smoking since > 1 year), alcohol consumption (Men > 30 g/d, Women > 20g/d) or illegal drugs Psychiatric disorders Risk for/or manifest AIDS (HIV) or Hepatitis B or C Night shift working Hypersensitivity to local anesthetics Cancer disease Lung diseases Systematic endurance training (>1x per week > 60min.) Maximal oxygen consumption (VO2 max) <20ml/min/kg Orthopedic disorders Musculoskeletal diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Roden, Prof., MD
Organizational Affiliation
German Diabetes Center
Official's Role
Study Director
Facility Information:
Facility Name
German Diabetes Center
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
34623918
Citation
Apostolopoulou M, Mastrototaro L, Hartwig S, Pesta D, Strassburger K, de Filippo E, Jelenik T, Karusheva Y, Gancheva S, Markgraf D, Herder C, Nair KS, Reichert AS, Lehr S, Mussig K, Al-Hasani H, Szendroedi J, Roden M. Metabolic responsiveness to training depends on insulin sensitivity and protein content of exosomes in insulin-resistant males. Sci Adv. 2021 Oct 8;7(41):eabi9551. doi: 10.1126/sciadv.abi9551. Epub 2021 Oct 8.
Results Reference
result
Links:
URL
https://ddz.de/
Description
Homepage

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Effect of High-intensity Low-volume Training on Insulin Sensitivity in Type 2 Diabetes

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